Quality Control Technician

Responsibilities

• Perform environmental monitoring of cleanrooms, including humidity and temperature checks and verification of pest control measures.
• Collect, prepare, and submit samples to various internal and external laboratories for further analysis.
• Verify and analyze test results to ensure they meet established specifications and quality system requirements.
• Prepare and mix chemical formulations for production and manufacturing use in accordance with SOPs.
• Execute in-process quality control tasks to monitor product and process performance during manufacturing.
• Maintain accurate maintenance records for all equipment used in quality control and production support.
• Perform daily pre-operational quality control checks of passivation chemistry to ensure proper performance.
• Conduct package visual inspections, seal strength testing, and integrity testing for sterile seals and pouching.
• Review sterilization certificates to determine readiness for full product release.
• Maintain accurate, complete, and organized records of all quality control activities and findings.
• Participate in quality control investigations and corrective and preventive actions (CAPAs) related to non-conformances.
• Verify that quality control measurements are accurate and document results with strong attention to detail.
• Ensure inspections are completed on time and aligned with production priorities and schedules.
• Review manufacturing records, including sterile processing data, test results, certifications, labeling, and paperwork to confirm compliance with specifications and quality system requirements.
• Perform batch record review for production lots to ensure completeness, accuracy, and adherence to procedures.
• Collaborate with third-party sterilization and contract testing laboratories by preparing devices for sterilization and entering sterility data into documentation systems.
• Support investigations by analyzing data from non-conformances and assisting in the development of investigation plans.
• Follow standard operating procedures consistently and escalate quality concerns when something appears out of scope.

Essential Skills

• Associates or Bachelor’s degree in a science-related discipline.
• At least 2 years of experience in a regulated industry such as medical device, pharmaceutical, or food.
• Demonstrated quality mindset and willingness to speak up when issues or out-of-scope activities are identified.
• Proven ability to follow standard operating procedures (SOPs), verified through references.
• Experience in quality control or quality assurance within a regulated environment.
• Hands-on experience with environmental monitoring in cleanrooms.
• Knowledge of microbiology principles and laboratory practices relevant to product and process testing.
• Understanding of Good Manufacturing Practices (GMP) and their application in daily work.
• Experience with sterilization processes and working with sterile products or environments.
• Ability to apply aseptic techniques when handling materials and samples.
• Experience supporting or executing corrective action plans and CAPAs.
• Strong investigation and analysis skills for evaluating non-conformances and quality issues.
• High attention to detail in documentation, record-keeping, and data entry.
• Ability to maintain accurate equipment maintenance and quality records.
• Capability to prepare and mix chemical formulations safely and accurately.
• Comfort working in both cleanroom and production environments and transitioning between hands-on and documentation tasks.

Additional Skills & Qualifications

• Experience in the medical device industry.
• Experience working with third-party sterilization laboratories or contract testing labs.
• At least 6 months of sterilization or environmental monitoring experience in a regulated environment such as medical device, pharmaceutical, food, brewery, or aerospace.
• References who can speak to your commitment to quality and adherence to SOPs.
• Interest in career advancement within Quality and willingness to grow into more senior quality roles over time.
• Ability to wear multiple hats and support various quality and production-related activities in a small, collaborative organization.

Work Environment

This role is fully on-site and split approximately 50% between cleanroom/production floor activities and 50% documentation